ABSTRACT
A clinical trial is a key step in the process of pharmaceutical research and development (R & D). It is a key indicator of the innovative potential of the pharmaceutical industry. ClinicalTrials.gov shows that the average annual growth rate of the total number of clinical trials globally in the past decade (2012-2021) was 20.7%, mainly distributed in Europe and the United States, and the total number of clinical trials registered in China accounted for 6% of the world. According to the statistics of IQVIA Institute for Human Data Science, the global proportion of early-stage R & D pipelines from China-headquartered companies increased from 1% in 2005 to 12% in 2020, which was still far behind that of European and American companies. Among 871 new active substances approved for marketing globally in the past two decades, 522 were for marketing in China, with the high number driven by regulatory acceleration mechanisms from National Medical Products Administration, such as breakthrough and orphan designations and priority reviews. Considering the gap in clinical research strength between China and developed countries such as Europe and the United States, the clinical trial research capacity and level should be improved to assist China in the R & D of innovative drugs. According to the Registration and Information Disclosure Platform for Drug Clinical Studies and the clinical trial institution filing management information platform in China, in the last five years (2017-2021), the average annual growth rates of the total number of new drug clinical trial registration and clinical trial units in China reached 26.9% and 12.6%, respectively. However, clinical trial resources are mainly concentrated in major institutions, municipalities, or provincial capital cities in the eastern and central regions of China, with distributions becoming increasingly polarised. Under the background of China's new medical reforms, the strategic direction of national political support is to motivate equitable access to high-quality clinical trial resources and cross-regional collaborative development of medical institutions by means of medical unions, national clinical medical research centres, Chinese national major projects for new drug innovation and so on. In the context of this background, clinical trial research unions (CTRUs) have been built in China. A CTRU is defined as a consortium formed by medical institutions, sponsors and third-party service institutions of various levels and functions, led by a national clinical medical research centre or clinical trial medical institutions undertaking major national science and technology projects or supporting projects of national key R & D plans, radiating and driving the improvement of clinical trial research capacity in multiple regions. CTRUs develop a multi-level clinical research centre system and collaborative network by vertically and horizontally combining multi-level medical institutions, sponsors and third-party service institutions. All participants of CTRUs are crucial. The leading clinical trial research medical institution, as the core, is responsible for establishing institutional system standards in CTRUs, designing and leading high-quality multi-centre clinical trials, central ethics and personality training. The major clinical trial research medical institutions are responsible for implementing high-quality, multi-centre, complex and high-risk clinical trials. The other member institutions are responsible for implementing basic clinical trials. The sponsors, contract research organizations (CROs), site management organizations (SMOs) and other enterprises are responsible for funding, supporting and promoting the construction of a clinical trial centre system and collaborative network. The specific construction contents of CTRUs include building a clinical trial research resource sharing platform, homogenising clinical trial quality management, constructing a rapid clinical trial process platform, diversified multi-level and multi-form talent training, information intercon ection, deepening strategic cooperation and designing and leading high-level trials. CTRUs have established the selection criteria and assessment exit mechanism and conducted work performance assessments from the dimensions of organisation and implementation, division of labour and cooperation, the connection of clinical trial resources from top to bottom, efficiency and benefit and sustainable development to ensure their good and sustainable development. Through CTRUs, we can achieve high-quality clinical trial resource sharing, improve the clinical trial research capability of member institutions, cultivate high-level skills, such as principal investigators (PIs), sub-investigators, institutional managers and clinical research coordinators (CRCs), and promote the development of clinical trials, economically and with high-quality. Through the trial operation with one member of CTRUs, it was found that the key points should be strengthened in deepening resource sharing, implementing central ethics review, interconnecting information platforms and leading high-quality clinical trials. The construction of CTRUs is an effective means for China's clinical trial research to solve the current problems and change from a `follow-on pattern' to leading high-level and high-quality international multi-centre trials. However, the construction of CTRUs is a complex systematic project. In addition to performing an excellent job in the top-level design and overall planning, CTRUs' specific implementation process and measures need to be continuously explored in the practice process.
ABSTRACT
With the rapid development of Artificial Intelligence (AI), deep learning has increasingly become a research hotspot in various fields, such as medical image classification. Traditional deep learning models use Bilinear Interpolation when processing classification tasks of multi-size medical image dataset, which will cause the loss of information of the image, and then affect the classification effect. In response to this problem, this work proposes a solution for an adaptive size deep learning model. First, according to the characteristics of the multi-size medical image dataset, the optimal size set module is proposed in combination with the unpooling process. Next, an adaptive deep learning model module is proposed based on the existing deep learning model. Then, the model is fused with the size fine-tuning module used to process multi-size medical images to obtain a solution of the adaptive size deep learning model. Finally, the proposed solution model is applied to the pneumonia CT medical image dataset. Through experiments, it can be seen that the model has strong robustness, and the classification effect is improved by about 4% compared with traditional algorithms.
ABSTRACT
In the context of the global pandemic of COVID-19, with the epidemic epicenter located in the Wuhan City, China, patients with severe mental illness have also been deeply affected by the epidemic. In this paper, two patients with schizophrenia who recovered from COVID-19 were reported. Because of the long-term positive results of the SARS-CoV-2 serum antibody IgM test, they had to undergo medical isolation and social restrictions for a long time. After the situation was effectively identified by the medical staff and they were eliminated as a potential virus carrier and released from the medical isolation center. Since psychiatrists often lack systematic knowledge of infectious diseases, the authors hope that this paper can provide a reference to avoid unnecessary wastage of medical resources and prevent placing serious mental burden on such patients in the future.